Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA

Medical University of Graz

Status: Unknown

Conditions: Osteo Arthritis Knee

Treatments: Procedure: Total Knee Arthroplasty

Study type: Observational

Funder types: Other

Identifiers

NCT04436211

032020

Details and patient eligibility

About

A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement.

Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required.

Thus, the kinematic alignment represents one of the few new developments in TKA.

Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure.

The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks.

In order to ensure comparability, patients are stratified regarding their age and gender before inclusion.

Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery.

This study is a monocentric, prospective, randomized and controlled open study.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Severe osteoarthritis of the knee joint, intended for total knee arthroplasty

Exclusion criteria

• malalignment with varus of more than 5° or valgus malpositioning, joint instability

Trial design

100 participants in 2 patient groups

TKA (mechanical alignment)

Treatment:

Procedure: Total Knee Arthroplasty

TKA (kinematic alignment)

Treatment:

Procedure: Total Knee Arthroplasty